WO2007010400A3 - Gastroretentive formulations and manufacturing process thereof - Google Patents

Gastroretentive formulations and manufacturing process thereof Download PDF

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Publication number
WO2007010400A3
WO2007010400A3 PCT/IB2006/002636 IB2006002636W WO2007010400A3 WO 2007010400 A3 WO2007010400 A3 WO 2007010400A3 IB 2006002636 W IB2006002636 W IB 2006002636W WO 2007010400 A3 WO2007010400 A3 WO 2007010400A3
Authority
WO
WIPO (PCT)
Prior art keywords
manufacturing process
gastroretentive formulations
gastroretentive
formulation
gelling agent
Prior art date
Application number
PCT/IB2006/002636
Other languages
French (fr)
Other versions
WO2007010400A2 (en
Inventor
Mahendra Chaudhari
Omprakash D Chandwani
Rajashree S Yelegaonkar
Original Assignee
Ethypharm Sa
Mahendra Chaudhari
Omprakash D Chandwani
Rajashree S Yelegaonkar
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethypharm Sa, Mahendra Chaudhari, Omprakash D Chandwani, Rajashree S Yelegaonkar filed Critical Ethypharm Sa
Priority to BRPI0612901A priority Critical patent/BRPI0612901B8/en
Priority to EP06795542A priority patent/EP1904034A2/en
Priority to CA2616081A priority patent/CA2616081C/en
Priority to AU2006271314A priority patent/AU2006271314B2/en
Priority to CN2006800265896A priority patent/CN101237858B/en
Priority to JP2008522096A priority patent/JP5199084B2/en
Priority to US11/996,023 priority patent/US9629800B2/en
Priority to KR1020087003902A priority patent/KR101367814B1/en
Publication of WO2007010400A2 publication Critical patent/WO2007010400A2/en
Publication of WO2007010400A3 publication Critical patent/WO2007010400A3/en
Priority to HK08113911.1A priority patent/HK1122729A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention concerns gastroretentive formulation comprising an active substance granulated with a mixture of a weak gelling agent, a strong gelling agent, and a gas generating agent and process for manufacturing said formulation.
PCT/IB2006/002636 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof WO2007010400A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
BRPI0612901A BRPI0612901B8 (en) 2005-07-19 2006-07-19 gastroretentive formulations and process for their preparation
EP06795542A EP1904034A2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
CA2616081A CA2616081C (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
AU2006271314A AU2006271314B2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
CN2006800265896A CN101237858B (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
JP2008522096A JP5199084B2 (en) 2005-07-19 2006-07-19 Stomach-retaining preparations and methods for producing them
US11/996,023 US9629800B2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
KR1020087003902A KR101367814B1 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
HK08113911.1A HK1122729A1 (en) 2005-07-19 2008-12-23 Gastroretentive formulations and manufacturing process thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP05291542.8 2005-07-19
EP05291542A EP1745775B1 (en) 2005-07-19 2005-07-19 Gastroretentive formulations and manufacturing process thereof.

Publications (2)

Publication Number Publication Date
WO2007010400A2 WO2007010400A2 (en) 2007-01-25
WO2007010400A3 true WO2007010400A3 (en) 2007-04-05

Family

ID=35517256

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2006/002636 WO2007010400A2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof

Country Status (13)

Country Link
US (1) US9629800B2 (en)
EP (2) EP1745775B1 (en)
JP (1) JP5199084B2 (en)
KR (1) KR101367814B1 (en)
CN (1) CN101237858B (en)
AT (1) ATE396710T1 (en)
AU (1) AU2006271314B2 (en)
BR (1) BRPI0612901B8 (en)
CA (1) CA2616081C (en)
DE (1) DE602005007205D1 (en)
HK (1) HK1122729A1 (en)
RU (1) RU2376983C2 (en)
WO (1) WO2007010400A2 (en)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20080076382A (en) * 2007-02-15 2008-08-20 (주)아모레퍼시픽 Controlled-release preparation containing cilostazol and process for the preparation thereof
EP2346351B1 (en) 2008-09-22 2019-07-03 Rubicon Research Private Limited Compositions exhibiting delayed transit through the gastrointestinal tract
FR2945947B1 (en) 2009-05-29 2011-07-29 Flamel Tech Sa FLOATING PHARMACEUTICAL COMPOSITIONS WITH CONTROLLED RELEASE
CA2767143A1 (en) 2009-07-06 2011-01-13 Kyorin Pharmaceutical Co., Ltd. Tablet having hollow structure
EP2361615A1 (en) 2010-02-19 2011-08-31 Alfred E. Tiefenbacher GmbH & Co. KG Dipyridamole prolonged-release tablet
EP2544666A2 (en) 2010-03-09 2013-01-16 Council of Scientific and Industrial Research Gastroretentive, extended release composition of therapeutic agent
RU2574018C2 (en) * 2010-03-31 2016-01-27 Мотида Фармасьютикал Ко., Лтд. Easily dosed solid medicinal preparation
CN101919817B (en) * 2010-07-23 2012-05-30 山东齐都药业有限公司 Lafutidine gastric-retention controlled-release composition
JP5976657B2 (en) 2011-09-30 2016-08-24 持田製薬株式会社 Easy-to-use solid preparation
DE102012102414A1 (en) 2012-03-21 2013-10-10 Michael Dittgen Composition, used to treat diabetes mellitus, includes antidiabetic drug as active substance, preferably metformin or its salt, where the composition is divided into two compartments, which include drug and three groups of adjuvants
WO2013168179A2 (en) * 2012-04-03 2013-11-14 Rubicon Research Private Limited Controlled release pharmaceutical formulations of antiviral agents
CN103110601B (en) * 2013-02-04 2014-10-29 成都恒瑞制药有限公司 Gliclazide gastric floating tablet and preparation method thereof
FR3014692B1 (en) * 2013-12-18 2016-01-29 Ethypharm Sa ORAL PHARMACEUTICAL COMPOSITIONS WITH GASTRIC RETENTION.
TWI705814B (en) * 2014-06-20 2020-10-01 美商梅琳塔有限責任公司 Pharmaceutical composition and use thereof
US11173135B2 (en) 2016-03-17 2021-11-16 Thiogenesis Therapeutics, Inc. Compositions for controlled release of cysteamine and systemic treatment of cysteamine sensitive disorders
CN107184560B (en) * 2017-06-03 2021-02-02 寿光富康制药有限公司 Metformin gastric retention tablet and preparation method thereof
JP7208982B2 (en) 2017-09-20 2023-01-19 チオジェネシス セラピューティクス， インコーポレイテッド Methods of Treating Cysteamine Sensitive Disorders
EP3740189A1 (en) * 2017-12-18 2020-11-25 Tris Pharma, Inc. Modified release drug powder composition comprising gastro-retentive raft forming systems having trigger pulse drug release
CA3085941A1 (en) 2017-12-18 2019-06-27 Tris Pharma, Inc. Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
CN109602714B (en) * 2018-12-29 2020-06-12 广东中润药物研发有限公司 Rivaroxaban gastric retention tablet and preparation method thereof
GB2599950A (en) * 2020-10-16 2022-04-20 Zentiva Ks Pharmaceutical compositions with low amounts of nitrosamine impurities and methods for producing the same
US20240065976A1 (en) * 2021-01-13 2024-02-29 DuPont Nutrition USA, Inc. A gastroretentive drug delivery system

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0425154A1 (en) * 1989-10-23 1991-05-02 Dow Corning France S.A. Sustained release elements
US6261601B1 (en) * 1997-09-19 2001-07-17 Ranbaxy Laboratories Limited Orally administered controlled drug delivery system providing temporal and spatial control
WO2001064183A1 (en) * 2000-03-03 2001-09-07 Ranbaxy Laboratories Limited Orally administered controlled delivery system for once daily administration of ciprofloxacin
US20030017189A1 (en) * 1998-12-23 2003-01-23 Patrick S.-L. Wong Gastric retaining oral liquid dosage form
US6548083B1 (en) * 1997-08-11 2003-04-15 Alza Corporation Prolonged release active agent dosage form adapted for gastric retention
WO2003097018A1 (en) * 2002-02-04 2003-11-27 Ranbaxy Laboratories Limited Hydrodynamically balancing oral drug delivery system with biphasic release
US6660300B1 (en) * 1998-03-19 2003-12-09 Bristol-Myers Squibb Co. Method of use of a biphasic controlled release delivery system for high solubility pharmaceuticals and method
US20030232081A1 (en) * 2002-06-04 2003-12-18 J. B. Chemicals & Pharmaceuticals Pharmaceutical composition for controlled drug delivery system

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61148115A (en) * 1984-12-21 1986-07-05 Tooa Eiyoo Kk Sustained release pharmaceutical of slightly soluble drug and production thereof
GB8618847D0 (en) * 1986-08-01 1986-09-10 Smith Kline French Lab Pharmaceutical formulations
US6635280B2 (en) 1997-06-06 2003-10-21 Depomed, Inc. Extending the duration of drug release within the stomach during the fed mode
UA73287C2 (en) * 1998-09-14 2005-07-15 Ranbaxy Lab Ltd Ciprofloxacin formulation with delayed release
US6797283B1 (en) 1998-12-23 2004-09-28 Alza Corporation Gastric retention dosage form having multiple layers
DK1140027T3 (en) * 1998-12-23 2006-02-27 Alza Corp Dosage forms containing porous particles
HUP0500795A3 (en) * 2001-07-04 2008-04-28 Sun Pharmaceutical Ind Ltd Gastric retention controlled drug delivery system
GB0205253D0 (en) * 2002-03-06 2002-04-17 Univ Gent Immediate release pharmaceutical granule compositions and a continuous process for making them
WO2005060942A1 (en) * 2003-12-19 2005-07-07 Aurobindo Pharma Ltd Extended release pharmaceutical composition of metformin

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0425154A1 (en) * 1989-10-23 1991-05-02 Dow Corning France S.A. Sustained release elements
US6548083B1 (en) * 1997-08-11 2003-04-15 Alza Corporation Prolonged release active agent dosage form adapted for gastric retention
US6261601B1 (en) * 1997-09-19 2001-07-17 Ranbaxy Laboratories Limited Orally administered controlled drug delivery system providing temporal and spatial control
US6660300B1 (en) * 1998-03-19 2003-12-09 Bristol-Myers Squibb Co. Method of use of a biphasic controlled release delivery system for high solubility pharmaceuticals and method
US20030017189A1 (en) * 1998-12-23 2003-01-23 Patrick S.-L. Wong Gastric retaining oral liquid dosage form
WO2001064183A1 (en) * 2000-03-03 2001-09-07 Ranbaxy Laboratories Limited Orally administered controlled delivery system for once daily administration of ciprofloxacin
WO2003097018A1 (en) * 2002-02-04 2003-11-27 Ranbaxy Laboratories Limited Hydrodynamically balancing oral drug delivery system with biphasic release
US20030232081A1 (en) * 2002-06-04 2003-12-18 J. B. Chemicals & Pharmaceuticals Pharmaceutical composition for controlled drug delivery system

Also Published As

Publication number Publication date
EP1745775B1 (en) 2008-05-28
BRPI0612901B1 (en) 2020-08-04
CA2616081C (en) 2013-09-10
CN101237858A (en) 2008-08-06
KR20080048461A (en) 2008-06-02
JP2009501777A (en) 2009-01-22
CA2616081A1 (en) 2007-01-25
WO2007010400A2 (en) 2007-01-25
US9629800B2 (en) 2017-04-25
BRPI0612901B8 (en) 2021-05-25
AU2006271314A1 (en) 2007-01-25
ATE396710T1 (en) 2008-06-15
EP1745775A1 (en) 2007-01-24
KR101367814B1 (en) 2014-02-27
RU2376983C2 (en) 2009-12-27
CN101237858B (en) 2012-07-04
HK1122729A1 (en) 2009-05-29
JP5199084B2 (en) 2013-05-15
BRPI0612901A2 (en) 2010-12-07
DE602005007205D1 (en) 2008-07-10
AU2006271314B2 (en) 2011-07-07
EP1904034A2 (en) 2008-04-02
RU2008106220A (en) 2009-08-27
US20080220060A1 (en) 2008-09-11

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